Trial Outcomes & Findings for Responses to Regulated E-Cigarette Advertisements (NCT NCT05207033)
NCT ID: NCT05207033
Last Updated: 2025-05-30
Results Overview
Use of any tobacco products
COMPLETED
NA
195 participants
1 month
2025-05-30
Participant Flow
Enrollment was N=195, however, prior to assignment, 9 participants stopped responding to communications from study staff including the initial survey, and thus were never assigned to a arm/group.
Participant milestones
| Measure |
Unregulated ad Condition
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media.
Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
|
Regulated ad Condition
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features.
Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
|
|---|---|---|
|
Overall Study
STARTED
|
94
|
92
|
|
Overall Study
COMPLETED
|
88
|
84
|
|
Overall Study
NOT COMPLETED
|
6
|
8
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Responses to Regulated E-Cigarette Advertisements
Baseline characteristics by cohort
| Measure |
Unregulated ad Condition
n=88 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media.
Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
|
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features.
Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
|
Total
n=172 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
88 Participants
n=99 Participants
|
84 Participants
n=107 Participants
|
172 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
22.13 years
STANDARD_DEVIATION 2.32 • n=99 Participants
|
22.88 years
STANDARD_DEVIATION 2.54 • n=107 Participants
|
22.5 years
STANDARD_DEVIATION 2.46 • n=206 Participants
|
|
Sex/Gender, Customized
female
|
67 Participants
n=99 Participants
|
69 Participants
n=107 Participants
|
136 Participants
n=206 Participants
|
|
Sex/Gender, Customized
male
|
16 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Sex/Gender, Customized
other
|
5 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
7 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
57 Participants
n=99 Participants
|
44 Participants
n=107 Participants
|
101 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
16 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
88 participants
n=99 Participants
|
84 participants
n=107 Participants
|
171 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 1 monthUse of any tobacco products
Outcome measures
| Measure |
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media.
Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
|
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features.
Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
|
|---|---|---|
|
Tobacco Use at 1 Month
|
5 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: 3 monthsUse of any tobacco products
Outcome measures
| Measure |
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media.
Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
|
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features.
Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
|
|---|---|---|
|
Tobacco Use at 3 Months
|
3 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 6 monthsUse of any tobacco products
Outcome measures
| Measure |
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media.
Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
|
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features.
Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
|
|---|---|---|
|
Tobacco Use at 6 Months
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 1 monthPerceived severity of using e-cigarettes, a subconstruct of the Health Belief Model was assessed by participants' perceived significance, severity, and seriousness of health threats from e-cigarette use. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 1 (strongly disagree) to 5 (strongly agree). I believe that the health threat of using e-cigarettes is severe. I believe that the health threat of using e-cigarettes is serious. I believe that the health threat of using e-cigarettes is significant. To determine score, the average is taken of the items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate greater perceived severity of e-cigarette use. Lower scores indicate lesser perceived severity of e-cigarette use.
Outcome measures
| Measure |
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media.
Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
|
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features.
Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
|
|---|---|---|
|
Perceived Severity of Using E-Cigarettes at 1 Month
|
4.41 units on a scale
Standard Deviation .66
|
4.46 units on a scale
Standard Deviation .61
|
PRIMARY outcome
Timeframe: 3 monthsPerceived severity of using e-cigarettes, a subconstruct of the Health Belief Model was assessed by participants' perceived significance, severity, and seriousness of health threats from e-cigarette use. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 1 (strongly disagree) to 5 (strongly agree). I believe that the health threat of using e-cigarettes is severe. I believe that the health threat of using e-cigarettes is serious. I believe that the health threat of using e-cigarettes is significant. To determine score, the average is taken of the items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate greater perceived severity of e-cigarette use. Lower scores indicate lesser perceived severity of e-cigarette use.
Outcome measures
| Measure |
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media.
Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
|
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features.
Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
|
|---|---|---|
|
Perceived Severity of Using E-Cigarettes at 3 Months
|
4.41 units on a scale
Standard Deviation .67
|
4.36 units on a scale
Standard Deviation .71
|
PRIMARY outcome
Timeframe: 6 monthsPerceived severity of using e-cigarettes, a subconstruct of the Health Belief Model was assessed by participants' perceived significance, severity, and seriousness of health threats from e-cigarette use. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 1 (strongly disagree) to 5 (strongly agree). I believe that the health threat of using e-cigarettes is severe. I believe that the health threat of using e-cigarettes is serious. I believe that the health threat of using e-cigarettes is significant. To determine score, the average is taken of the items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate greater perceived severity of e-cigarette use. Lower scores indicate lesser perceived severity of e-cigarette use.
Outcome measures
| Measure |
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media.
Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
|
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features.
Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
|
|---|---|---|
|
Perceived Severity of Using E-Cigarettes at 6 Months
|
4.48 units on a scale
Standard Deviation .63
|
4.48 units on a scale
Standard Deviation .59
|
PRIMARY outcome
Timeframe: 1 MonthMotivation to avoid e-cigarettes was assessed by participants' self-reported importance, confidence, readiness, and commitment to avoid e-cigarette use in the future. These items reflect constructs from behavior change theories such as the Transtheoretical Model, which emphasizes individual readiness and self-efficacy as key predictors of behavioral intention and action. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 0 to 10. 0 = Not at all 10 = Very How important is it to avoid e-cigarettes in the future? How confident are you in avoiding e-cigarettes in the future? How ready are you to avoid e-cigarettes in the future? How committed are you to avoid e-cigarettes in the future? To determine score, the average is taken across the four items. Minimum Score = 0; Maximum Score = 10 Higher scores indicate greater motivation to avoid e-cigarette use. Lower scores indicate lesser motivation.
Outcome measures
| Measure |
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media.
Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
|
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features.
Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
|
|---|---|---|
|
Motivation to Avoid E-Cigarettes at 1 Month
|
7.66 score on a scale
Standard Deviation 2.03
|
8.05 score on a scale
Standard Deviation 1.89
|
PRIMARY outcome
Timeframe: 3 MonthsMotivation to avoid e-cigarettes was assessed by participants' self-reported importance, confidence, readiness, and commitment to avoid e-cigarette use in the future. These items reflect constructs from behavior change theories such as the Transtheoretical Model, which emphasizes individual readiness and self-efficacy as key predictors of behavioral intention and action. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 0 to 10. 0 = Not at all 10 = Very How important is it to avoid e-cigarettes in the future? How confident are you in avoiding e-cigarettes in the future? How ready are you to avoid e-cigarettes in the future? How committed are you to avoid e-cigarettes in the future? To determine score, the average is taken across the four items. Minimum Score = 0; Maximum Score = 10 Higher scores indicate greater motivation to avoid e-cigarette use. Lower scores indicate lesser motivation.
Outcome measures
| Measure |
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media.
Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
|
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features.
Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
|
|---|---|---|
|
Motivation to Avoid E-Cigarettes at 3 Months
|
7.74 score on a scale
Standard Deviation 2.13
|
8.02 score on a scale
Standard Deviation 1.87
|
PRIMARY outcome
Timeframe: 6 MonthsMotivation to avoid e-cigarettes was assessed by participants' self-reported importance, confidence, readiness, and commitment to avoid e-cigarette use in the future. These items reflect constructs from behavior change theories such as the Transtheoretical Model, which emphasizes individual readiness and self-efficacy as key predictors of behavioral intention and action. The measure is as follows in its exact and unabbreviated form: Please rate the following statements on a scale from 0 to 10. 0 = Not at all 10 = Very How important is it to avoid e-cigarettes in the future? How confident are you in avoiding e-cigarettes in the future? How ready are you to avoid e-cigarettes in the future? How committed are you to avoid e-cigarettes in the future? To determine score, the average is taken across the four items. Minimum Score = 0; Maximum Score = 10 Higher scores indicate greater motivation to avoid e-cigarette use. Lower scores indicate lesser motivation.
Outcome measures
| Measure |
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media.
Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
|
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features.
Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
|
|---|---|---|
|
Motivation to Avoid E-Cigarettes at 6 Months
|
7.87 score on a scale
Standard Deviation 2.08
|
8.00 score on a scale
Standard Deviation 1.87
|
PRIMARY outcome
Timeframe: 1 monthBehavioral intentions to use e-cigarettes were assessed using participants' self-reported interest and willingness to engage in future e-cigarette use. This construct is grounded in the Theory of Planned Behavior, which identifies behavioral intention as the most immediate and reliable predictor of future behavior. The measure is as follows in its exact and unabbreviated form: How interested are you in trying e-cigarettes? How willing are you to try e-cigarettes? How willing would you be to purchase an e-cigarette? How willing would you be to try an e-cigarette if a friend offered you one? Responses were rated on a scale from 1 (not at all) to 5 (very). To determine score, the average is taken across the four items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate stronger behavioral intentions to use e-cigarettes. Lower scores indicate weaker intentions.
Outcome measures
| Measure |
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media.
Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
|
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features.
Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
|
|---|---|---|
|
Behavioral Intentions at 1 Month
|
3.23 score on a scale
Standard Deviation .76
|
3.32 score on a scale
Standard Deviation .76
|
PRIMARY outcome
Timeframe: 3 monthsBehavioral intentions to use e-cigarettes were assessed using participants' self-reported interest and willingness to engage in future e-cigarette use. This construct is grounded in the Theory of Planned Behavior, which identifies behavioral intention as the most immediate and reliable predictor of future behavior. The measure is as follows in its exact and unabbreviated form: How interested are you in trying e-cigarettes? How willing are you to try e-cigarettes? How willing would you be to purchase an e-cigarette? How willing would you be to try an e-cigarette if a friend offered you one? Responses were rated on a scale from 1 (not at all) to 5 (very). To determine score, the average is taken across the four items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate stronger behavioral intentions to use e-cigarettes. Lower scores indicate weaker intentions.
Outcome measures
| Measure |
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media.
Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
|
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features.
Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
|
|---|---|---|
|
Behavioral Intentions at 3 Months
|
3.19 score on a scale
Standard Deviation .83
|
3.37 score on a scale
Standard Deviation .80
|
PRIMARY outcome
Timeframe: 6 monthsBehavioral intentions to use e-cigarettes were assessed using participants' self-reported interest and willingness to engage in future e-cigarette use. This construct is grounded in the Theory of Planned Behavior, which identifies behavioral intention as the most immediate and reliable predictor of future behavior. The measure is as follows in its exact and unabbreviated form: How interested are you in trying e-cigarettes? How willing are you to try e-cigarettes? How willing would you be to purchase an e-cigarette? How willing would you be to try an e-cigarette if a friend offered you one? Responses were rated on a scale from 1 (not at all) to 5 (very). To determine score, the average is taken across the four items. Minimum Score = 1; Maximum Score = 5 Higher scores indicate stronger behavioral intentions to use e-cigarettes. Lower scores indicate weaker intentions.
Outcome measures
| Measure |
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media.
Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
|
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features.
Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
|
|---|---|---|
|
Behavioral Intentions at 6 Months
|
3.24 score on a scale
Standard Deviation .75
|
3.20 score on a scale
Standard Deviation .88
|
PRIMARY outcome
Timeframe: 1 monthBiochemical confirmation of tobacco use was conducted using the Alere iScreen Oral Fluid Device (OFD), a point-of-care saliva test that detects cotinine, a primary metabolite of nicotine, indicating tobacco or nicotine product use within the past \~3 days. The count reflects participants who tested positive for cotinine, providing biochemical evidence of recent tobacco or nicotine exposure.
Outcome measures
| Measure |
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media.
Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
|
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features.
Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
|
|---|---|---|
|
Number of Participants With Biochemical Verification of Tobacco Use at 1 Month
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: 3 monthsBiochemical confirmation of tobacco use was conducted using the Alere iScreen Oral Fluid Device (OFD), a point-of-care saliva test that detects cotinine, a primary metabolite of nicotine, indicating tobacco or nicotine product use within the past \~3 days. The count reflects participants who tested positive for cotinine, providing biochemical evidence of recent tobacco or nicotine exposure.
Outcome measures
| Measure |
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media.
Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
|
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features.
Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
|
|---|---|---|
|
Number of Participants With Biochemical Verification of Tobacco Use at 3 Months
|
1 Participants
|
2 Participants
|
PRIMARY outcome
Timeframe: 6 monthsBiochemical confirmation of tobacco use was conducted using the Alere iScreen Oral Fluid Device (OFD), a point-of-care saliva test that detects cotinine, a primary metabolite of nicotine, indicating tobacco or nicotine product use within the past \~3 days. The count reflects participants who tested positive for cotinine, providing biochemical evidence of recent tobacco or nicotine exposure.
Outcome measures
| Measure |
Unregulated ad Condition
n=87 Participants
This arm will include exposure to unregulated e-cigarette ads or ads as they appear in modern media.
Unregulated ad condition: This intervention will determine if unrestricted appealing features in e-cigarette ads deter young adults from trying the product.
|
Regulated ad Condition
n=84 Participants
This arm will include exposure to regulated e-cigarette ads or ads where we have taken out the appealing features.
Regulated ad condition: This intervention will determine if restriction of appealing features in e-cigarette ads deter young adults from trying the product.
|
|---|---|---|
|
Number of Participants With Biochemical Verification of Tobacco Use at 6 Months
|
0 Participants
|
3 Participants
|
Adverse Events
Unregulated ad Condition
Regulated ad Condition
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Elise Stevens, Assistant Professor
University of Massachusetts Chan Medical School
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place